Tag Archives: nano silver

I’ve grumbled more than once or twice about the seemingly secret society that is Canada’s nanotechnology effort (especially health, safety, and environment issues) and the fact that I get most my information from Organization for Economic Cooperation and Development (OECD) documents. That said, thank you to Lynne Bergeson’s April 8, 2016 post on Nanotechnology Now for directions to the latest OECD nano document,

The Organization for Economic Cooperation and Development recently posted a March 29, 2016, report entitled Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table. … The report compiles information, provided by Working Party on Manufactured Nanomaterials (WPMN) participating delegations, before and after the November 2015 WPMN meeting, on current developments on the safety of manufactured nanomaterials.

It’s an international roundup that includes: Australia, Austria, Belgium, Canada, Germany, Japan, Korea, the Netherlands, Switzerland, Turkey, United Kingdom, U.S., and the European Commission (EC), as well as the Business and Industry Advisory Committee to the OECD (BIAC) and International Council on Animal Protection in OECD Programs (ICAPO).

CANADA
National developments on human health and environmental safety including recommendations, definitions, or discussions related to adapting or applying existing regulatory systems or the drafting of new laws/ regulations/amendments/guidance materials A consultation document on a Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List was published with a public comment period ending on May 17, 2015. The proposed approach outlines the Government’s plan to address nanomaterials considered in commerce in Canada (on Canada’s public inventory). The proposal is a stepwise approach to acquire and evaluate information, followed by any necessary action. A follow-up stakeholder workshop is being planned to discuss next steps and possible approaches to prioritize future activities. The consultation document is available at: http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=1D804F45-1

A mandatory information gathering survey was published on July 25, 2015. The purpose of the survey is to collect information to determine the commercialstatus of certain nanomaterials in Canada. The survey targets 206 substances considered to be potentially in commerce at the nanoscale. The list of 206 substances was developed using outcomes from the Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative to identify nanomaterial types. These nanomaterial types were cross-referenced with the Domestic Substances List to develop a preliminary list of substances which are potentially intentionally manufactured at the nanoscale. The focus of the survey aligns with the Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List (see above) and certain types of nanomaterials were excluded during the development of the list of substances. The information being requested by the survey includes substance identification, volumes, and uses. This information will feed into the Government’s proposed approach to address nanomaterials on the Domestic Substances List. Available at: http://gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php

Four substances were notified to the program since the WPMN14 – three surface modified substances and one inorganic substance. No actions, including additional data requests, were taken due to low expected exposures in accordance with the New Substances Notifications Regulations (Chemicals and Polymers) (NSNR) for two of the substances. Two of the substances notified were subject to a Significant New Activity Notice. A Significant New Activity notice is an information gathering tool used to require submission of additional information if it is suspected that a significant new activity may result in the substance becoming toxic under the Canadian Environmental Protection Act, 1999.

b.Proposals, or modifications to previous regulatory decisions

As part of the Government’s Chemicals Management Plan, a review is being undertaken for all substances which have been controlled through Significant New Activity (SNAc) notices (see above). As part of this activity, the Government is reviewing past nanomaterials SNAc notices to see if new information is available to refine the scope and information requirements. As a result of this review, 9 SNAc notices previously in place for nanomaterials have been rescinded. This work is ongoing, and a complete review of all nanomaterial SNAcs is currently planned to be completed in 2016.

Information related to good practice documents

The Canada-led, ISO standards project, ISO/DTR 19716 Nanotechnologies — Characterization of cellulose nanocrystals, [emphasis mine] initiated in April 2014, is now at Committee Draft (CD) 3-month ISO ballot, closing Aug 31, 2015. Ballot comments will be addressed during JWG2 Measurement and Characterization working group meetings at the 18th Plenary of ISO/TC229, Nanotechnologies, being held in Edmonton, Alberta, Sep. 28 – Oct. 2, 2015.

Research programmes or strategies designed to address human health and/ or environmental safety aspects of nanomaterials

Scientific research

Environment Canada continues to support various academic and departmental research projects. This research has to date included studying fate and effects of nanomaterials in the aquatic, sediment, soil, and air compartments. Funding in fiscal 2015-16 continues to support such projects, including sub-surface transportation, determining key physical-chemical parameters to predict ecotoxicity, and impacts of nano-silver [silver nanoparticles] addition to a whole lake ecosystem [Experimental Lakes Area?]. Environment Canada has also partnered with the National Research Council of Canada recently to initiate a project on the development of test methods to identify surfaces of nanomaterials for the purposes of regulatory identification and to support risk assessments. In addition, Environment Canada is working with academic laboratories in Canada and Germany to prepare guidance to support testing of nanoparticles using the OECD Test Guideline for soil column leaching.

Health Canada continues its research efforts to investigate the effects of surface-modified silica nanoparticles. The aims of these projects are to: (1) study the importance of size and surface functionalization; and (2) provide a genotoxic profile and to identify mechanistic relationships of particle properties to elicited toxic responses. A manuscript reporting the in vitro genotoxic, cytotoxic and transcriptomic responses following exposure to silica nanoparticles has recently been submitted to a peer reviewed journal and is currently undergoing review. Additional manuscripts reporting the toxicity results obtained to date are in preparation.

Information on public/stakeholder consultations;

A consultation document on a Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List was published with a public comment period ending on May 17, 2015 (see Question 1). Comments were received from approximately 20 stakeholders representing industry and industry associations, as well as non-governmental organizations. These comments will inform decision making to address nanomaterials in commerce in Canada.

Information on research or strategies on life cycle aspects of nanomaterials

Canada, along with Government agencies in the United States, Non-Governmental Organizations and Industry, is engaged in a project to look at releases of nanomaterials from industrial consumer matrices (e.g., coatings). The objectives of the NanoRelease Consumer Products project are to develop protocols or
methods (validated through interlaboratory testing) to measure releases of nanomaterials from solid matrices as a result of expected uses along the material life cycle for consumer products that contain the nanomaterials. The project is currently in the advanced stages of Phase 3 (Interlaboratory Studies). The objectives of Phase 3 of the project are to develop robust methods for producing and collecting samples of CNT-epoxy and CNT-rubber materials under abrasion and weathering scenarios, and to detect and quantify, to the extent possible, CNT release fractions. Selected laboratories in the US, Canada, Korea and the European Community are finalising the generation and analysis of sanding and weathering samples and the results are being collected in a data hub for further interpretation and analysis.

Additional details about the project can be found at the project website: http://www.ilsi.org/ResearchFoundation/RSIA/Pages/NanoRelease1.aspx

Under the OECD Working Party on Resource Productivity and Waste (WPRPW), the expert group on waste containing nanomaterials has developed four reflection papers on the fate of nanomaterials in waste treatment operations. Canada prepared the paper on the fate of nanomaterials in landfills; Switzerland on the recycling of waste containing nanomaterials; Germany on the incineration of waste containing nanomaterials; and France on nanomaterials in wastewater treatment. The purpose of these papers is to provide an overview of the existing knowledge on the behaviour of nanomaterials during disposal operations and identify the information gaps. At the fourth meeting of the WPRPW that took place on 12-14 November 2013, three of the four reflection papers were considered by members. Canada’s paper was presented and discussed at the fifth meeting of the WPRPRW that took place on 8-10 December 2014. The four papers were declassified by EPOC in June 2015, and an introductory chapter was prepared to draw these papers together. The introductory chapter and accompanying papers will be published in Fall 2015. At the sixth meeting of the WPRPW in June – July 2015, the Secretariat presented a proposal for an information-sharing platform that would allow delegates to share research and documents related to nanomaterials. During a trial phase, delegates will be asked to use the platform and provide feedback on its use at the next meeting of the WPRPW in December 2015. This information-sharing platform will also be accessible to delegates of the WPMN.

Information related to exposure measurement and exposure mitigation.

Canada and the Netherlands are co-leading a project on metal impurities in carbon nanotubes. A final version of the report is expected to be ready for WPMN16. All research has been completed (e.g. all components are published or in press and there was a presentation by Pat Rasmussen to SG-08 at the Face-to-Face Meeting in Seoul June 2015). The first draft will be submitted to the SG-08 secretariat in autumn 2015. Revisions will be based on early feedback from SG-08 participants. The next steps depend on this feedback and amount of revision required.

Information on past, current or future activities on nanotechnologies that are being done in co-operation with non-OECD countries.

A webinar between ECHA [European Chemicals Agency], the US EPA [Environmental Protection Agency] and Canada was hosted by Canada on April 16, 2015. These are regularly scheduled trilateral discussions to keep each other informed of activities in respective jurisdictions.

In March 2015, Health Canada hosted 3 nanotechnology knowledge transfer sessions targeting Canadian government research and regulatory communities working in nanotechnology. These sessions were an opportunity to share information and perspectives on the current state of science supporting the regulatory oversight of nanomaterials with Government. Presenters provided detailed outputs from the OECD WPMN including: updates on OECD test methods and guidance documents; overviews of physical-chemical properties, as well as their relevance to toxicological testing and risk assessment; ecotoxicity and fate test methods; human health risk assessment and alternative testing strategies; and exposure measurement and mitigation. Guest speakers included Dr Richard C. Pleus Managing Director and Director of Intertox, Inc and Dr. Vladimir Murashov Special Assistant on Nanotechnology to the Director of National Institute for Occupational Safety and Health (NIOSH).

On March 4-5, 2015, Industry Canada and NanoCanada co-sponsored “Commercializing Nanotechnology in Canada”, a national workshop that brought together representatives from industry, academia and government to better align Canada’s efforts in nanotechnology. This workshop was the first of its kind in Canada. It also marked the official launch of NanoCanada (http://nanocanada.com/), a national initiative that is bringing together stakeholders from across Canada to bridge the innovation gap and stimulates emerging technology solutions.

It’s nice to get an update about what’s going on. Despite the fact this report was published in 2016 the future tense is used in many of the verbs depicting actions long since accomplished. Maybe this was a cut-and-paste job?

Moving on, I note the mention of the Canada-led, ISO standards project, ISO/DTR 19716 Nanotechnologies — Characterization of cellulose nanocrystals (CNC). For those not familiar with CNC, the Canadian government has invested hugely in this material derived mainly from trees, in Canada. Other countries and jurisdictions have researched nanocellulose derived from carrots, bananas, pineapples, etc.

Finally, it was interesting to find out about the existence of NanoCanada. In looking up the Contact Us page, I noticed Marie D’Iorio’s name. D’Iorio, as far as I’m aware, is still the Executive Director for Canada’s National Institute of Nanotechnology (NINT) or here (one of the National Research Council of Canada’s institutes). I have tried many times to interview someone from the NINT (Nils Petersen, the first NINT ED and Martha Piper, a member of the advisory board) and more recently D’Iorio herself only to be be met with a resounding silence. However, there’s a new government in place, so I will try again to find out more about the NINT, and, this time, NanoCanada.

The study included 3-, 7-, and 14-day exposures to American Biotech Labs 10-ppm (15 ml/day) silver solution in a double-blind, placebo controlled, cross-over phase design. Healthy volunteer subjects (36, 12 per each time-exposure), underwent complete metabolic, blood and platelet count, urinalysis tests, sputum hyperresponsiveness and inflammation evaluation, physical examinations, vital sign measurements, and magnetic resonance imaging of the chest and abdomen at baseline and at the end of each phase.

… Keith Moeller, A Managing Director at ABL. “… As a prelim to the study, I volunteered to be checked for silver deposition in my body, after 15+ years of almost daily usage as a supplement to help boost my immune system. No silver residue was found anywhere in my system. We are always working hard to gain knowledge about silver. Because of this, we have now amassed a library of more than 300 major reports, studies and test series, all completed on our nano-silver technology by more than 60 different universities, government/military labs, and private institutions.”

Oddly, I cannot find where this study was published nor does the news release, which originated the news item, appear on the company website (as of 4 pm PDT April 23, 2013).

As for the study itself, which researchers ran the study? Was a third party contracted to run it? How did they ensure the study was double-blind? I gather this was not a randomized study.

They state specifically there were no urine changes. If the subjects are eliminating the silver, shouldn’t they be able to see that in the urine? If the silver accumulates in the body, how much is too much? Might it not take longer than 14 days to reach a toxic or dangerous stage?

Moeller’s personal endorsement is not really convincing as one assumes that as managing director of the company he has much to gain by encouraging people to ingest nano silver (ABL sells it as a health supplement). The same holds true regarding this study, which seems to have been run by the company itself.

As it stands, the study seems a bit sketchy but hopefully more details will emerge.

Thanks for Lynn L. Bergeson for her Dec. 1, 2012 posting on the Nanotechnology Now website for the information about a Nov. 28, 2012 webinar that was held to discuss a Nanotechnology Work Plan developed by the joint Canada-US Regulatory Cooperation Council (or sometimes it’s called the US-Canada Regulatory Cooperation Council),

…

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

To compare risk assessment and risk management practices to highlight and identify best practices, data gaps, and differences between the two jurisdictions, the RCC sought nominations of a nanomaterial substance for a case study. Four nanomaterial substances were nominated: multiwall carbon nanotubes, nanocrystalline cellulose, nano silver, and titanium dioxide. The RCC has selected multiwall carbon nanotubes for the case study. The RCC intends to hold in March 2013 a workshop in Washington, D.C., to discuss information collected to date and approaches moving forward. In spring 2013, the RCC will hold one or two conference calls or webinars to discuss information gathered between countries and the path forward. Finally, in fall 2013, the RCC expects to hold a stakeholder consultation/workshop on results to date.

Safety and security framework & arrangement for the St. Lawrence Seaway & Great Lakes System

Marine transportation security regulations

Recreational boat manufacturing standards

Standard for lifejackets

Rail Transport

Locomotive Emissions

Rail Safety Standards

Environment

Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

Electronic submission gateway

Over-the-counter products – common monographs

Good manufacturing practices

Occupational Safety Issues

Classification & labelling of workplace hazardous chemicals

Nanotechnology

Nanotechnology

Led jointly by senior officials from Canada and the United States, the purpose of the various technical review sessions was to seek expert advice and technical input from the approximately 240 stakeholders in attendance.

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome: Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.

Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

3-6 months:

Canada provides initial feedback on US “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.

6-12 months:

Countries complete an initial draft of shared principles for the regulation of nanomaterials.

Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/US review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials [Canada is a lead in the OECD Working Party on Manufactured Nanomaterials]).

According to Empa researchers, Bernd Nowack and Harald Krug, together with Murray Heights of the company HeiQ, silver at the nanoscale has a long history. From the Jan. 31,2011 news item on physorg.com,

Nanosilver is not a new discovery by nanotechnologists — it has been used in various products for over a hundred years, as is shown by a new Empa study. The antimicrobial effects of minute silver particles, which were then known as “colloidal silver,” were known from the earliest days of its use.

Their paper showing that nanosilver is not a 21st century discovery is being published in Environmental Science & Technology. From the news item,

Silver particles with diameters of seven to nine nm were mentioned as early as 1889. They were used in medications or as biocides to prevent the growth of bacteria on surfaces, for example in antibacterial water filters or in algaecides for swimming pools.

The nanoparticles were known as “colloidal silver” in those days, but what was meant was the same then as now – extremely small particles of silver. The only new aspect is the use today of the prefix “nano”. “However,” according to Bernd Nowack, “nano does not mean something new, and nor does it mean something that is harmful.” When “colloidal silver” became available on the market in large quantities in the 1920s it wasthe topic of numerous studies and subject to appropriate regulation by the authorities. [emphasis mine]

This suggests that there has been sufficient research on what we now call nano silver and its impact on the environment and on health. By contrast, the California Department of Toxic Substances Control (DTSC) had this to say in its recent call for information about analytical test methods for nanomaterials (from the Dec. 27, 2010 news item on Nanowerk),

Silver has been known historically as a potent antibacterial, antifungal, and antiviral agent. In recent years, silver is used as a biocide in solution, suspension, and in nano-particulate form. The strong antimicrobial activity is a major reason for the development of products that contain nano silver. Nano silver may also have applications in agricultural, vector, and urban pest control. However, little or no information about detecting and measuring the effect of nano silver in the environment exists. Recent published papers point out difficulties in quantifying the existence of nano particles in environmental and biological contexts, which presents challenges in estimating and assessing the hazards and risks of nano silver. [emphasis mine]

Nowack, one of the Empa researchers, provides evidence for his position in a commentary that was previously published in the journal Science (from the news item),

A commentary by Bernd Nowack in the scientific journal Science discusses the implications of the newest studies on nanosilver in sewage treatment plants. More than 90% remains bound in the sewage sludge in the form of silver sulfide, a substance which is extremely insoluble and orders of magnitude less poisonous than free silver ions. [emphasis mine] It apparently does not matter what the original form of the silver in the wastewater was, whether as metallic nanoparticles, as silver ions in solution or as precipitated insoluble silver salts.

“As far as the environmental effects are concerned, it seems that nanosilver in consumer goods is no different than other forms of silver and represents only a minor problem for eco-systems,” says Nowack. What is still to be clarified, however, is in what form the unbound silver is present in the treated water released from sewage works, and what happens to the silver sulfide in natural waters. Is this stable and unreactive or is it transformed into other forms of silver? [emphasis mine]

The two approaches are not directly contradictory but I do find the totality confusing. Which challenges about the hazards and risks of nano silver are the folks in California referring to? It seems they’re not familiar with the older research cited by Nowack or perhaps they know something Nowack and his colleagues do not. Meanwhile, Nowack’s Science commentary is reassuring but whoever wrote the news item was careful to point out that there is still some important work to be done before declaring nano silver to be a ‘safe’ substance.

A little late but better than never, the US state of California has issued a call for information focused on analytical test methods, i.e., lab procedures for testing, nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots. The deadline for a response is Dec. 21, 2011, one year from the date of the request. From the Dec. 27, 2010 news item on Nanowerk,

DTSC [Department of Toxic Substances Control] has conducted a search of known public sources for analytical test methods for these six nanomaterials. We have compiled our research in this bibliography. DTSC has also contacted and consulted with manufacturers, researchers, environmental laboratory experts, other governments, and stakeholders regarding analytical test methods for these nanomaterials in these matrices. We convened public workshops and symposia on nanotechnology and, in particular, these six nanomaterials.

From our research, consultations, and workshops, we have determined that little or no information on analytical test methods for these nanomaterials in the human body or the environment now exists. To better understand the behavior, fate and transport of the se six nanomaterials, appropriate analytical test methods are needed for manufacturers, for contract and reference laboratories, and for regulatory agencies.

You can get more information about the call from the DTSC site including a list of companies that received the ‘call for information’ letter.